Comparison of Erector Spina Plane Block and Thoracic Epidural Block
Primary Purpose
Breast Neoplasms, Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector spina plane block before general anaesthesia
Thoracic epidural block before general anaesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
- ASA(American Society of Anesthesiologist) physical classification I-III
- Patients undergoing unilateral mastectomies due to malignancy
Exclusion Criteria:
- Active infection at the intervention site
- History of coagulopathy or anticoagulant use (less time has passed before peripheral and central blocks)
- Major cardiac, pulmonary, renal and neurological diseases
- Autonomic neuropathy or use of drugs that affect autonomic function
- Patients with type 1 diabetes or insulin dependent type 2 diabetes over 10 years
- Allergic to local anesthetics;
- Patients who are uncooperative or have psychiatric problems
- Morbidly obese (body mass index > 35 kg/m2)
Sites / Locations
- Eskisehir Osmangazi University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group E
Group T
Arm Description
Patients who receive general anesthesia after erector spina plane block
Patients who receive general anesthesia after thoracic epidural block
Outcomes
Primary Outcome Measures
Sympathetic block level evaluation with skin conductivity
Skin conductivity will be measured by galvanic skin response (GSR)
Sympathetic block level evaluation with skin temperature
Skin temperature of bilateral thorax will be measured
Sympathetic block level evaluation with hot cold test
Hot cold test of bilateral thorax will be measured
Sympathetic block level evaluation by hemodynamic data
Peri-operative heart rate and mean arterial pressure will be recorded
Sensorial block level evaluation
By pin-prick test
Secondary Outcome Measures
intraoperative hemodynamic data
Heart rate and mean arterial pressure
Postoperative pain scores
Pain score will be measured with visual analog scale (0-no pain; 10-worst pain) during movement and rest.
Rescue analgesics consumption
Amount of remifentanil (microgram)
Rescue analgesics consumption
Amount of tramadol (milligram)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04702061
Brief Title
Comparison of Erector Spina Plane Block and Thoracic Epidural Block
Official Title
Comparison of Erector Spina Plane Block and Thoracic Epidural Block in Breast Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this randomised controlled and double-blind study, is to compare the effects of erector spinae plane (ESP) and thoracic epidural (TEA) blocks on peri-operative hemodynamics and analgesia in patients undergoing unilateral mastectomies due to malignancy.
Detailed Description
Patients will be randomised into two groups as Group E (those who received general anesthesia after the erector spina plan block) and Group T (those who received general anesthesia after thoracic epidural block).
After the block skin conductivity (galvanic skin response - GSR), body temperature changes, sympathetic and sensory block levels, peri-operative hemodynamic data, postoperative pain scores and analgesic consumption will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group E
Arm Type
Active Comparator
Arm Description
Patients who receive general anesthesia after erector spina plane block
Arm Title
Group T
Arm Type
Active Comparator
Arm Description
Patients who receive general anesthesia after thoracic epidural block
Intervention Type
Other
Intervention Name(s)
Erector spina plane block before general anaesthesia
Intervention Description
After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be directed between the erector spina muscle and the transverse process of the T4 vertebra using the in-plane technique. The location of the needle will be confirmed by hydrodissection with saline after touching the transverse process. After the plan open, 5 ml of 2% lidocaine, 10 ml of 0.5% bupivacaine and 10 ml of saline, including hydrodissection, will be given in a total amount of 25 ml. Then a 20-G epidural catheter will be inserted 3-4 cm and fixed.
Intervention Type
Other
Intervention Name(s)
Thoracic epidural block before general anaesthesia
Intervention Description
After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be entered through the T4-5 interspinous space (median or paramedian approach). After reaching the thoracic epidural area by loss of resistance method, the epidural catheter will be advanced and fixed to remain 3-4 cm in the epidural area. Following the test dose (2 ml of 2% lidocaine), 3 ml of 2% lidocaine, 5 ml of 0.5% bupivacaine and 5 ml of saline will be administered intermittently in a total volume of 15 ml.
Primary Outcome Measure Information:
Title
Sympathetic block level evaluation with skin conductivity
Description
Skin conductivity will be measured by galvanic skin response (GSR)
Time Frame
45 minutes after block administration
Title
Sympathetic block level evaluation with skin temperature
Description
Skin temperature of bilateral thorax will be measured
Time Frame
45 minutes after block administration
Title
Sympathetic block level evaluation with hot cold test
Description
Hot cold test of bilateral thorax will be measured
Time Frame
45 minutes after block administration
Title
Sympathetic block level evaluation by hemodynamic data
Description
Peri-operative heart rate and mean arterial pressure will be recorded
Time Frame
45 minutes after block administration
Title
Sensorial block level evaluation
Description
By pin-prick test
Time Frame
45 minutes after block administration
Secondary Outcome Measure Information:
Title
intraoperative hemodynamic data
Description
Heart rate and mean arterial pressure
Time Frame
During the operation
Title
Postoperative pain scores
Description
Pain score will be measured with visual analog scale (0-no pain; 10-worst pain) during movement and rest.
Time Frame
24 hours after operation
Title
Rescue analgesics consumption
Description
Amount of remifentanil (microgram)
Time Frame
During the operation and 24 hours after operation
Title
Rescue analgesics consumption
Description
Amount of tramadol (milligram)
Time Frame
24 hours after operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA(American Society of Anesthesiologist) physical classification I-III
Patients undergoing unilateral mastectomies due to malignancy
Exclusion Criteria:
Active infection at the intervention site
History of coagulopathy or anticoagulant use (less time has passed before peripheral and central blocks)
Major cardiac, pulmonary, renal and neurological diseases
Autonomic neuropathy or use of drugs that affect autonomic function
Patients with type 1 diabetes or insulin dependent type 2 diabetes over 10 years
Allergic to local anesthetics;
Patients who are uncooperative or have psychiatric problems
Morbidly obese (body mass index > 35 kg/m2)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulay ERDOGAN KAYHAN, MD
Organizational Affiliation
Professor Doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir Osmangazi University
City
Eskişehir
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Comparison of Erector Spina Plane Block and Thoracic Epidural Block
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